Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR,INC. MODELS 1

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR SABLE(TM) PTCA CATHETER

IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK

FDA 510(k)

FDA Class 2 ·Ophthalmic

UROVANTAGE

FDA 510(k)

FDA Class 2 ·Radiology

UROLOGIC

FDA 510(k)

FDA Class 2 ·Radiology

STONELITH, MODEL V5

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LITHODIAMOND ULTRA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LIFE-TEL L.B.E.(LIFE-PAK 5/10 BATTERY ELIMINATOR)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SURGI PAK NE AND COCOMENT EUGENAL FREE PASTE SYST

FDA 510(k)

FDA Class 2 ·Dental

CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK

FDA 510(k)

FDA Class 2 ·Immunology

SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003

FDA 510(k)

FDA Class 2 ·General Hospital

BAXTER CA DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BAXTER BIOSTAT 1000 UREA MONITOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BAXTER APD 12' EXTENSION LINE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BAXTER CT DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LASER RESISTANT DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery